Cleared Traditional

K030821 - SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5

K030821 is an FDA 510(k) clearance for SIMUPLAN TREATMENT PLANNING SYSTEM, manufactured by Simuplan S.L.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K030821 · Simuplan S.L. · Radiology device
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Sep 2003
Decision
187d
Days
Class 2
Risk

K030821 is an FDA 510(k) clearance for the SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Simuplan S.L. (La Eliana Valencia, ES). The FDA issued a Cleared decision on September 17, 2003 after a review of 187 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Simuplan S.L. devices

FDA 510(k) Submission Details - K030821

510(k) Number K030821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2003
Decision Date September 17, 2003
Days to Decision 187 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 107d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 161
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K030821.
ONCENTRA-VISIR
K041719 · Nucletron Corp. · Jul 2004
ACCUSOFT
K040474 · Direx Systems Corp. · Jun 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · Adac Laboratories · Oct 2003
NOMOS CORVUS 5.0M
K032209 · Nomos Corp. · Aug 2003
OTP 1.2
K031349 · Nucletron Corp. · Aug 2003
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · Siemens Medical Solutions USA, Inc. · Nov 2002